Efficacy and safety of tildrakizumab in Japanese patients with moderate to severe plaque psoriasis: Results from a 64‐week phase 3 study (reSURFACE 1)
| Autor: | Yukari Okubo, Shigetoshi Sano, Masaru Honma, Alan M. Mendelsohn, Yayoi Tada, Atsuyuki Igarashi, Akimichi Morita, Hidemi Nakagawa, Shinichi Imafuku, Masaki Kawamura, Mamitaro Ohtsuki |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
medicine.medical_specialty interleukin‐23 subunit p19 Population Tildrakizumab monoclonal Dermatology Placebo Antibodies Monoclonal Humanized Severity of Illness Index law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method Japan law Psoriasis Area and Severity Index Internal medicine Psoriasis tildrakizumab medicine antibodies Humans education Adverse effect Body surface area education.field_of_study humanized business.industry General Medicine Original Articles psoriasis medicine.disease Treatment Outcome 030220 oncology & carcinogenesis randomized controlled trial Japanese Original Article business |
| Zdroj: | The Journal of Dermatology |
| ISSN: | 1346-8138 0385-2407 |
| Popis: | Tildrakizumab is a high‐affinity, humanized immunoglobulin G1κ, anti‐interleukin‐23p19 monoclonal antibody recently approved in Japan for treatment of plaque psoriasis. We report results from Japanese patients treated with tildrakizumab in the multinational, randomized, double‐blind, placebo‐controlled reSURFACE 1 study (clinicaltrials.gov NCT01722331). Adults with moderate to severe plaque psoriasis were randomized (2:2:1) to receive subcutaneous tildrakizumab 100 or 200 mg or placebo every 12 weeks. Placebo recipients were rerandomized to tildrakizumab 100 or 200 mg at week 12. The global study coprimary endpoints were the proportions of patients achieving 75% improvement from baseline Psoriasis Area and Severity Index (PASI 75) and Physician Global Assessment (PGA) response (0/1 with ≥2 grade reduction from baseline) at week 12. Analyses included 158 Japanese patients randomized to tildrakizumab 100 (n = 64) or 200 mg (n = 62) or placebo (n = 32). Japanese patients had higher mean baseline body surface area involvement and PASI versus all reSURFACE 1 patients. At week 12, significantly more Japanese patients receiving tildrakizumab 100 and 200 mg versus placebo achieved PASI 75 (54.7% and 54.8% vs 6.3%, respectively, both nominal p 80% of patients achieving PASI 75 or PASI 90 at week 28 and continuing tildrakizumab treatment at the same dose maintained response at week 64. From baseline to week 28, absolute PASI decreased from >12 in all patients to ≤2 in >40% and ≤3 in >50% of patients receiving tildrakizumab. Tildrakizumab was generally well tolerated with an adverse event profile similar to that of placebo. Tildrakizumab treatment was associated with durable efficacy in Japanese patients with moderate to severe plaque psoriasis despite greater baseline disease severity versus the global reSURFACE 1 population. |
| Databáze: | OpenAIRE |
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